FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
9265–9288 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K232311 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 12d
Cleared Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
K232162 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared Aug 14, 2023
Electro-Spec Steri-Caps
K231905 · HTY
Electro-Spec, Inc.
Orthopedic · 46d
Cleared Aug 14, 2023
DESS Dental Smart Solutions
K231434 · NHA
Terrats Medical SL
Dental · 89d
Cleared Aug 14, 2023
ENDOGATOR™ Hybrid Irrigation Tubing
K231418 · OCX
Medivators
Gastroenterology & Urology · 90d
Cleared Aug 14, 2023
Organic cotton tampon, Viscose tampon
K231341 · HEB
Zhejiang Tianqing Manufacturing...
Obstetrics & Gynecology · 97d
Cleared Aug 14, 2023
Stryker Resorbable Fixation System
K231208 · HBW
Stryker Leibinger GmbH & Co KG
Neurology · 109d
Cleared Aug 14, 2023
V-Laser
K231054 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 123d
Cleared Aug 14, 2023
Yomi Robotic System
K231018 · PLV
Neocis, Inc.
Dental · 126d
Cleared Aug 14, 2023
Density
K230663 · GEI
Jeisys Medical, Inc.
General & Plastic Surgery · 157d
Cleared Aug 14, 2023
SPICCA Stand-Alone Cervical Fusion Cages
K230608 · OVE
Southern Medical (Pty) , Ltd.
Orthopedic · 164d
Cleared Aug 14, 2023
SPICCA Cervical Fusion Cages
K230607 · ODP
Southern Medical (Pty) , Ltd.
Orthopedic · 164d
Cleared Aug 14, 2023
SaintView
K223660 · LLZ
Inviz Corporation
Radiology · 251d
Cleared Aug 12, 2023
TK Pre-Filled Normal Saline Flush Syringe
K230756 · NGT
Anhui Tiankang Medical Technology...
General Hospital · 145d
Cleared Aug 12, 2023
Pulse Oximeter
K230172 · DQA
Beijing Choice Electronic Technology...
Anesthesiology · 204d
Cleared Aug 12, 2023
Pre-Filled Normal Saline Flush Syringe
K223584 · NGT
Anhui Tianyang Pharmaceutical Co., Ltd.
General Hospital · 254d
Cleared Aug 11, 2023
NOxBOXi Nitric Oxide Delivery System
K231823 · MRN
Linde Gas & Equipment, Inc.
Anesthesiology · 51d
Cleared Aug 11, 2023
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
K231696 · KLE
Prevest Denpro Limited
Dental · 60d
Cleared Aug 11, 2023
NITINEX Memory Compression Staple
K231493 · JDR
Vilex, LLC
Orthopedic · 80d
Cleared Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439 · LZA
S&S Glove Corporation
General Hospital · 86d
Cleared Aug 11, 2023
Erchonia FX-405
K231409 · NHN
Erchonia Corporation
Physical Medicine · 88d
Cleared Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408 · LZA
Shandong Intco Medical Products Co, Ltd.
General Hospital · 88d
Cleared Aug 11, 2023
Electronic Blood Pressure Monitor
K230642 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 156d
Cleared Aug 11, 2023
VersiHD with GuideMe software
K230632 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 157d